HIV, Buprenorphine, and the Criminal Justice System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- CD4 Count Absolute
研究概览
简要总结
The aims of STRIDE were changed as of July, 2014. The revised project, called STRIDE2, has a longitudinal, non-randomized, observational study design. The population under study consists of individuals living with HIV who are dependent on opioids.
详细描述
Presented in the results section are the summary of outcomes from the STRIDE RCT that were collected prior to the change in study design. The STRIDE study became STRIDE2 (NCT03583138). Those individuals originally enrolled in the STRIDE RCT will be followed for 12 months.
STRIDE2 will assist in identifying and monitoring individuals' HIV risk behaviors and provide resources to seek treatment for their HIV care and substance use. The goal of STRIDE2 is to examine if there are differences in HIV, drug use, and other outcomes between individuals receiving treatment versus individuals actively using, not actively using and not in treatment, and individuals on Methadone, Suboxone, or in some other treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 yrs
- •Meets DSM-IV criteria for opioid dependence
- •Has medical entitlements in DC
- •Able to provide informed consent
- •Able to communicate in English or Spanish
排除标准
- •Being prescribed an opiate medication for a chronic pain condition or expressing the need to be placed on chronic pain medical conditions for a documented pain condition
- •Currently receiving methadone dosing of over 30 mg per day and uninterested in changing to buprenorphine
- •AST and ALT >5x the upper limit of normal (AST≥175, ALT≥195)
- •Pregnant or unwilling to use contraception (including OCPs, patch, Depo-Provera, condoms, etc.)
- •Breastfeeding or unwilling to stop breastfeeding
- •Subject is part of another pharmacological research study
- •Liver dysfunction (acute hepatitis, liver failure or hepatic dysfunction)
- •Suicidal ideation
- •Hypersensitivity to buprenorphine
研究组 & 干预措施
Buprenorphine
干预措施: Buprenorphine/naloxone (Drug)
Placebo
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
CD4 Count Absolute
时间窗: 12 Months
CD4 Count
Viral Load
时间窗: 12 Months
Viral Load
Log Viral Load
时间窗: 12 Months
Log Viral Load
CD4 Percent
时间窗: 12 Months
CD4 Percent
次要结局
- Improved Criminal Justice Outcomes(baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52)
- Improved Opioid Treatment Outcomes(baseline, 3 months, 9 months, 12 months)